High blood cholesterol (hypercholesterolemia) is recognized as being a risk factor in cardiovascular disease which comprises a major health care problem today. Epidemiological studies have demonstrated that, with few exceptions, populations consuming large quantities of saturated fat and cholesterol have a relatively high concentration of serum cholesterol and a high mortality rate from coronary heart disease. A regimen for alleviating or preventing hypercholesterolemia is to reduce fat intake by using reduced calorie fats or a fat substitute (i.e. non-absorbable, non-digestible fat), in particular, polyol fatty acid polyesters, and more specifically the sugar fatty acid polyesters.
While desired for treating hypercholesterolemia, the sugar fatty acid polyesters interfere with the body's absorption of fat soluble vitamins, see for example U.S. Pat. No. 4,005,196 and U.S. Pat. No. 4,034,083. Any oil soluble vitamins which are dissolved in the sugar fatty acid polyesters are lost when the nondigestible fat passes through the digestive track.
Heretofore, the composition containing sugar fatty acid polyesters are fortified with increased levels of the fat soluble vitamins to overcome possible vitamin malabsorption. However, higher vitamin fortification levels can impart taste, odor and color negatives to the product. For example U.S. Pat. No. 5,248,504 discloses a product containing oil-soluble vitamins, digestible fat and indigestible polyol fatty acid polyesters which comprises two distinct fat phases, A and B, both of which contain a fat soluble vitamin. The fat phase (B) contains an oil-soluble vitamin at a concentration level that is at least twice as high as the concentration level of fat phase (A). Further, fat phase (A) comprises indigestible polyol fatty acid polyesters, which have been shown to interfere with the absorption of oil-soluble vitamins. It has also been taught, see for example EPO 415,464A2, to use compounds which have reduced hydrophobicity. Although reducing hydrophobicity may reduce the loss of oil soluble vitamins, the vitamins are still essentially water-insoluble.
An important fat-soluble vitamin is vitamin A. Beta-carotene is a well known vitamin A precursor and is the most commonly used source of vitamin A for nutritional supplementation. Beta-carotene is also reported to protect cells from free radicals that may induce cancer and atherosclerosis.
The present invention relates to a combination of non-absorbable and non-digestible fat and water-soluble beta carotene. The loss of the oil soluble vitamins can be overcome by adding beta-carotene of the type disclosed hereinafter to fat substitutes, or to foods containing these fat substitutes. The present invention, the beta-carotene is complexed with cyclodextrin, resulting in a water soluble beta-carotene. While not wishing to be bound by theory, it is believed that the beta-carotene complex prefers the aqueous phase in the body rather than the fat or fat-like phase. It therefore becomes more bioavailable, i.e., it does not leave the body with the non-digestible, non-absorbable fat and can therefore be utilized by the body. Fortification of products containing the non-digestible, non-absorbable fat with the water-soluble, bioavailable form of beta-carotene requires a lower usage level of the vitamin precursor to offset the effects of lowered serum levels, thus reducing the cost of fortification. Because the beta-carotene is encapsulated the color, flavor and stability negatives associated with high vitamin usage levels are minimized.